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Hematopoietic and Lymphatic System NeoplasmPhase 2NCT07390968

Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Patients

A Phase 2 study testing SARS-CoV-2 mRNA Vaccine ARCT-021, Tozinameran and Biospecimen Collection in people with Hematopoietic and Lymphatic System Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This phase IIb trial compares the effect of LUNAR-COV19 vaccine to Comirnaty vaccine in treating adult patients who have received a hematopoietic cell transplant (HCT). Guidelines recommend repeating severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccination of 3 messenger ribonucleic acid (mRNA)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SARS-CoV-2 mRNA Vaccine ARCT-021, Tozinameran and Biospecimen Collection
Type of treatment
Vaccines, Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
1 Dec 2026to 1 Jan 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥ 18 years
  • Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (where locally approved)
  • Have received an allogeneic HCT within the prior 365 days
  • Have no relapse or progression of underlying malignancy
  • Have platelets ≥ 30,000/mm^3
  • Not pregnant (confirmed with negative urine or serum pregnancy test, if applicable)
  • Willingness to take study vaccine and complete necessary study procedures
  • If of childbearing potential, must agree to use a highly effective method of birth control or abstain from heterosexual activity for the course of the study through at least 60 days after the last dose of the study vaccine

Who cannot join

  • Current infection with SARS-CoV-2 or infection within the prior 28 day period
  • Positive for SARS-CoV-2 by nasal swab polymerase chain reaction (PCR) at screening
  • Currently receiving any approved, authorized, or investigational direct-acting antiviral drug against SARS-CoV-2
  • Received any approved, authorized, or investigational monoclonal anti-SARS-CoV-2 antibody therapy within the prior 180 days before screening
  • Received a SARS-CoV-2 vaccine after HCT or within 28 days prior to HCT
  • Participation in any other concurrent clinical trial of an experimental treatment or prevention for SARS-CoV-2
Show all 13Show fewer
  • Receiving > 1 mg/kg/day corticosteroids within the prior 7 days
  • Active infection that is not adequately controlled, as determined by the investigator
  • Have received therapies that cause profound T-cell or B-cell depletion within 30 days of enrollment, or anticipated to receive such therapies within 3 months of enrollment
  • Have received immunoglobulin replacement therapy (IGRT) within 30 days of enrollment, or anticipated to receive IGRT within 3 months of enrollment
  • Have a history of suspected or documented myocarditis or pericarditis
  • Any inability to take study vaccine or comply with study procedures that, in the opinion of the investigator, would make the participant unsuitable for the study
  • Individuals with a known history of severe hypersensitivity reactions, including anaphylaxis, or other significant adverse reactions to any vaccine or any vaccine excipient. Have any other condition that would, in the investigator's judgment, contraindicate participation in the clinical study due to safety concerns with clinical study procedures

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Joshua Hill, MD contact

206-667-6504

jahill3@fredhutch.org

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

    Joshua Hill, MD, 206-667-6504, jahill3@fredhutch.org

    Joshua Hill, MD

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Double-Blind, Randomized, Controlled Trial of the Safety and Immunogenicity of a Self-Amplifying mRNA COVID-19 Vaccine in Adult Hematopoietic Cell Transplant Recipients

This phase IIb trial compares the effect of LUNAR-COV19 vaccine to Comirnaty vaccine in treating adult patients who have received a hematopoietic cell transplant (HCT). Guidelines recommend repeating severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccination of 3 messenger ribonucleic acid (mRNA) vaccines followed by a fourth booster 3-6 months after treatment. However, vaccination is less effective in HCT patients compared to healthy people due to impaired immune responses. LUNAR-COV19, a self-amplifying mRNA vaccine, may help the body's own immune system recognize the SARS-CoV-2 spike protein and fight the virus by using a special mRNA that copies itself for a stronger response. Vaccines made from mRNA with SARS-CoV-2, such as Comirnaty, may help the body build an effective immune response. This may provide active protection against SARS-CoV-2 infection. LUNAR-COV19 may be safe and tolerable and may generate a better and more durable immune response than the Comirnaty vaccine in adult patients who have received a HCT.

Read the detailed description

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive LUNAR-COV19 intramuscularly (IM) on days 1, 29 and 113 in the absence of medical conditions or unacceptable toxicity. Additionally, patients undergo nasal swab at screening and at time of suspected SARS-CoV-2 infection, as well as blood sample collection throughout the study.

ARM II: Patients receive SARS-CoV-2 Comirnaty IM on days 1, 29 and 113 in the absence of medical conditions or unacceptable toxicity. Additionally, patients undergo nasal swab at screening and at time of suspected SARS-CoV-2 infection, as well as blood sample collection throughout the study.

After completion of study treatment, patients are followed up at days 115, 120, 127, 141 and 281.

Being tested
SARS-CoV-2 mRNA Vaccine ARCT-021, Tozinameran, Biospecimen Collection, Electronic Health Record Review, Survey Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARS-CoV-2 mRNA Vaccine ARCT-021Biological

    Also called ARCT 021, ARCT-021, ARCT-021 COVID-19 Vaccine, ARCT-021 SARS-CoV-2 Vaccine

    Given IM

  • TozinameranBiological

    Also called BNT 162b2, BNT-162b2, BNT1162b2 SARS-CoV-2 Vaccine, BNT162b2

    Given IM

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected

    Undergo nasal swab and blood sample collection

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT07390968
Study groupRoleWhat they receive
Arm I (LUNAR-COV19)ExperimentalPatients receive LUNAR-COV19 IM on days 1, 29 and 113 in the absence of medical conditions or unacceptable toxicity. Additionally, patients undergo nasal swab at screening and at time of suspected SARS-CoV-2 infection, as well as blood sample collection throughout the study.
Receives: Biological: SARS-CoV-2 mRNA Vaccine ARCT-021; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Survey Administration
Arm II (Comirnaty)ExperimentalPatients receive SARS-CoV-2 Comirnaty IM on days 1, 29 and 113 in the absence of medical conditions or unacceptable toxicity. Additionally, patients undergo nasal swab at screening and at time of suspected SARS-CoV-2 infection, as well as blood sample collection throughout the study.
Receives: Biological: Tozinameran; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric mean titer (GMT) of neutralizing antibody (nAb) against spike protein matching the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant

    Will compare log10-transformed SARS-CoV-2 nAb titers at 28 days following the third vaccination (day 141) between study arms using linear mixed effects models with fixed effects for time points when nAb titers are measured up until day 141 (days 29, 113, and 141; baseline as the reference category), study arm, the interaction between time points and study arm, and stratification variables (time since hematopoietic cell transplantation [HCT] and site). Subject-specific random effects will be included. Model estimates will be exponentiated and presented as a ratio of GMTs, with 90% confidence intervals, to correspond with the two-sided alpha of 0.10 used for power calculations.

    Measured: At 28 days after the third vaccine dose, assessed up through day 141

Secondary outcomes (8)

  1. Percentage of participants with one or more solicited local or systemic reactogenicity signs and symptoms

    Will tabulate the number and severity of solicited local or systemic reactogenicity signs and symptoms overall and by randomization group. Will compare the probability of at least one solicited local reaction or systemic adverse event after each vaccination dose by randomization arm using generalized linear mixed effects models, with logit link, similar to the models described for the seroresponse outcome.

    Measured: For up to 7 days following each vaccination

  2. Percentage of participants with unsolicited adverse events (AEs)

    Will tabulate the number and severity of unsolicited AEs overall and by randomization group. Will also report the number and percentage of participants with at least one of each of these types of AEs, by dose, severity, and study arm. The probability of at least one unsolicited AE will be compared between study arms using similar models.

    Measured: Up to 28 days following each vaccination

  3. Percentage of participants with one or more serious AEs, or AEs of special interest (AESIs)

    Will tabulate the number and severity of serious AEs or AESIs overall and by randomization group. Will also report the number and percentage of participants with at least one of each of these types of AEs, by dose, severity, and study arm. The probability of at least one serious AE or AESI will be compared by study arms using time-to-event methods.

    Measured: Following first study vaccine dose until 6 months following last vaccination

  4. nAb GMT against spike protein matching the SARS-CoV-2 variant included in the vaccine

    Measured: At 28-84 days after each vaccine dose, and at 6 months after the last dose

  5. Anti-spike immunoglobulin G GMT against Spike protein matching the SARS-CoV-2 variant included in the vaccine

    Measured: At 28-84 days after each vaccine dose, and at 6 months after the last dose

  6. Seroresponse rates

    Will be defined as the proportion of participants with a 4-fold or greater increase in nAb titers. Will be compared by study arm using mixed effects models, but with a binomial distribution and logit link, and using the baseline nAb as a covariate rather than a dependent variable. Comparisons from these models will be presented as odds ratios with 95% confidence intervals. Per-protocol (PP) analyses among the PP cohort may be performed as a sensitivity analysis.

    Measured: At 28-84 days after each vaccine dose, and at 6 months after the last dose

  7. Quantitative levels of anti-Spike T cell responses

    Will be based on a validated intracellular cytokine staining assay demonstrating interferon-γ, interleukin-2, or both.

    Measured: At 28-84 days after each vaccine dose, and at 6 months after the last dose

  8. New events of late-acute or chronic graft-versus-host disease (GVHD) of grade 3 or higher

    Will compute the cumulative incidence of late-acute or chronic GVHD of grade 3 or higher by randomization arm using time-to-event methods.

    Measured: Up to day 141

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07390968
Sponsor's protocol ID
RG1125827
Other IDs
NCI-2026-00148, 20962
Status last verified
Jan 2026
First submitted
29 Jan 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SARS-CoV-2 mRNA Vaccine ARCT-021, Tozinameran and Biospecimen Collection in people with Hematopoietic and Lymphatic System Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joshua Hill, MD (206-667-6504, jahill3@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric mean titer (GMT) of neutralizing antibody (nAb) against spike protein matching the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant (time frame: At 28 days after the third vaccine dose, assessed up through day 141). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07390968.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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